Application 205360

Type: ANDA
Sponsor: AVET

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXERCALCIFEROL	DOXERCALCIFEROL	CAPSULE;ORAL	0.5MCG	No	No
002	DOXERCALCIFEROL	DOXERCALCIFEROL	CAPSULE;ORAL	1MCG	No	No
003	DOXERCALCIFEROL	DOXERCALCIFEROL	CAPSULE;ORAL	2.5MCG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A205360-001	DOXERCALCIFEROL	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	AB		2020-09-15
A205360-002	DOXERCALCIFEROL	DOXERCALCIFEROL	1MCG	CAPSULE / ORAL	AB		2020-09-15
A205360-003	DOXERCALCIFEROL	DOXERCALCIFEROL	2.5MCG	CAPSULE / ORAL	AB	RS	2020-09-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A205360-001	AB
A205360-002	AB
A205360-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205360-001	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	AB		2020-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205360-002	DOXERCALCIFEROL	1MCG	CAPSULE / ORAL	AB		2020-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205360-003	DOXERCALCIFEROL	2.5MCG	CAPSULE / ORAL	AB	RS	2020-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205360-001	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	AB		2020-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205360-002	DOXERCALCIFEROL	1MCG	CAPSULE / ORAL	AB		2020-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205360-003	DOXERCALCIFEROL	2.5MCG	CAPSULE / ORAL	AB	RS	2020-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205360-001	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	AB		2020-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205360-002	DOXERCALCIFEROL	1MCG	CAPSULE / ORAL	AB		2020-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205360-003	DOXERCALCIFEROL	2.5MCG	CAPSULE / ORAL	AB		2020-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205360-001	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	AB		2020-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205360-002	DOXERCALCIFEROL	1MCG	CAPSULE / ORAL	AB		2020-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205360-003	DOXERCALCIFEROL	2.5MCG	CAPSULE / ORAL	AB		2020-09-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205360-001	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	AB		2020-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205360-002	DOXERCALCIFEROL	1MCG	CAPSULE / ORAL	AB		2020-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205360-003	DOXERCALCIFEROL	2.5MCG	CAPSULE / ORAL	AB		2020-09-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205360-001	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	AB		2020-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205360-002	DOXERCALCIFEROL	1MCG	CAPSULE / ORAL	AB		2020-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205360-003	DOXERCALCIFEROL	2.5MCG	CAPSULE / ORAL	AB		2020-09-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205360-001	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	AB		2020-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205360-002	DOXERCALCIFEROL	1MCG	CAPSULE / ORAL	AB		2020-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205360-003	DOXERCALCIFEROL	2.5MCG	CAPSULE / ORAL	AB		2020-09-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205360-001	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	AB		2020-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205360-002	DOXERCALCIFEROL	1MCG	CAPSULE / ORAL	AB		2020-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205360-003	DOXERCALCIFEROL	2.5MCG	CAPSULE / ORAL	AB		2020-09-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205360-001	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	AB		2020-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205360-002	DOXERCALCIFEROL	1MCG	CAPSULE / ORAL	AB		2020-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205360-003	DOXERCALCIFEROL	2.5MCG	CAPSULE / ORAL	AB		2020-09-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205360-001	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	AB		2020-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205360-002	DOXERCALCIFEROL	1MCG	CAPSULE / ORAL	AB		2020-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205360-003	DOXERCALCIFEROL	2.5MCG	CAPSULE / ORAL	AB		2020-09-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205360-001	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	AB		2020-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205360-002	DOXERCALCIFEROL	1MCG	CAPSULE / ORAL	AB		2020-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205360-003	DOXERCALCIFEROL	2.5MCG	CAPSULE / ORAL	AB		2020-09-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205360-001	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	AB		2020-09-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205360-002	DOXERCALCIFEROL	1MCG	CAPSULE / ORAL	AB		2020-09-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205360-003	DOXERCALCIFEROL	2.5MCG	CAPSULE / ORAL	AB		2020-09-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205360-001	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	AB		2020-09-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205360-002	DOXERCALCIFEROL	1MCG	CAPSULE / ORAL	AB		2020-09-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205360-003	DOXERCALCIFEROL	2.5MCG	CAPSULE / ORAL	AB		2020-09-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205360-001	DOXERCALCIFEROL	0.5MCG	CAPSULE / ORAL	AB		2020-09-15	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205360-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205360-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205360-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205360-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205360-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205360-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205360-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205360-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205360-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205360-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205360-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205360-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205360-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205360-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205360-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205360-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205360-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205360-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205360-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205360-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205360-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205360-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205360-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205360-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205360-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205360-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205360-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205360-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205360-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205360-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205360-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205360-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205360-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205360-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205360-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205360-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205360-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205360-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205360-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205360-001	AB	1	`8072bd15b7f6…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxercalciferol	DOXERCALCIFEROL	REMEDYREPACK INC.	943a3f95-842c-455f-9050-3d1c3971c6f8	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205360 application number: ANDA205360
Doxercalciferol	DOXERCALCIFEROL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	2ed2f592-27a7-4c10-a18a-21a3f221d3b1	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205360 application number: ANDA205360 ndc (product): 23155-538 ndc (product): 23155-539 ndc (product): 23155-540
Doxercalciferol	DOXERCALCIFEROL	Chartwell RX, LLC	356fb38a-791c-48f0-9312-6203ae57d80c	2024-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205360 application number: ANDA205360

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23155-538	Doxercalciferol	Doxercalciferol	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-538	Doxercalciferol	Doxercalciferol	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-539	Doxercalciferol	Doxercalciferol	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-539	Doxercalciferol	Doxercalciferol	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-540	Doxercalciferol	Doxercalciferol	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-540	Doxercalciferol	Doxercalciferol	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current